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Clinical Trials in China / NCT07284888
Recruiting Observational

Practices of Prone Positioning Ventilation in Patients With Moderate-to-Severe ARDS in Intensive Care Units: A Registry-Based Observational Study

NCT07284888 · tracked via the Priya Life Science China tracker
Sponsor
Southeast University, China
Phase
Observational
Started
2026-01-01
Last updated
2026-01-02

Condition(s) studied

Acute Respiratory Distress Syndrome

Investigational drug(s) / intervention(s)

Prone position ventilation

Prone position ventilation: Patients underwent prone positioning while receiving invasive mechanical ventilation

Study summary

Acute respiratory distress syndrome (ARDS) is a major cause of mortality in intensive care units. Prone position ventilation (PPV) is an important component of ARDS management and has been shown to reduce mortality in patients with moderate-to-severe ARDS. However, substantial heterogeneity exists in treatment response to PPV. Previous studies suggest that lung morphology-focal versus non-focal patterns based on chest CT-may influence responses to ventilatory strategies, but whether lung morphology modifies the effect of PPV remains unclear. In addition, the benefits and safety of PPV in patients with acute brain injury (ABI) complicated by ARDS are uncertain. Although PPV improves oxygenation, it may impair cerebral venous drainage and increase intracranial pressure, raising concerns about its use in ABI patients. Evidence from randomized trials in this population is limited and excludes patients with more severe hypoxemia or elevated intracranial pressure.

Furthermore, the optimal duration and termination criteria for PPV are not well established. While PPV improves alveolar recruitment and reduces ventilator-induced lung injury, prolonged PPV may lead to excessive sedation exposure and PPV-related complications. Identifying the appropriate timing to discontinue PPV may help balance clinical benefits and potential harms.This study is a prospective, multicenter registry enrolling patients with moderate-to-severe ARDS. The objectives are: (1) To determine whether lung morphology can guide individualized PPV strategies; (2) To evaluate the effectiveness and safety of PPV in patients with ARDS complicated by acute brain injury; (3) To investigate the optimal timing for termination of PPV through target trial emulation methods.In addition to these core objectives, the study will include other exploratory aims.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1.Age ≥ 18 years 2. Moderate-to-severe ARDS requiring invasive mechanical ventilation, defined as: 1. PaO₂/FiO₂ ≤ 150 mm Hg, 2. PEEP ≥ 5 cm H₂O, 3. ARDS diagnosed according to the 2023 Global Definition. Exclusion Criteria: 1.Refusal of informed consent by the patient's legally authorized representative

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhongda Hospital, School of Medicine, Southeast University Nanjing Jiangsu Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07284888 on ClinicalTrials.gov ↗ ← All trials in China